Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies Food allergies affect 15 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13, in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there are no approved therapies for food allergies anywhere in the world. Food allergies are expected to grow 10% annually until 2022. It is also common for someone to have more than one allergy. This is a growing, underserved global market that has few treatment options. A meaningful initial therapy would be one that reduces the chance for anaphylactic reaction after accidental exposure. Based on surveys, allergists and patients believe a therapy that reduces the chance for anaphylactic reaction from accidental exposure is meaningful and worthwhile. Such a therapy will help bring peace of mind to families, allow for children affected by food allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for death from accidental procedure. The approximate healthcare burden per patient is $3,000-4,000 per year. Moonlight Therapeutics is developing a targeted way to administer peanut allergens into the top skin layers to desensitize an allergic patient. Delivery is achieved using microneedles, which are minimally invasive and painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility. Because the delivery is in top and superficial skin layers, the approach is expected to produce little to no systemic adverse reactions. We have demonstrated efficacy of our approach in a pre-clinical mouse model of peanut sensitization. In this STTR Fast-Track grant application Moonlight Therapeutics has proposed aims that will allow it to file an investigational new drug (IND) application with the FDA for first-in-human trials. In Phase 1, four aims are proposed to develop processes for producing peanut allergen proteins and coated MNs with strict quality assurance and operating procedures that can be transferred to cGMP production. An efficacy study in animals is also proposed in Phase 1. Appropriate milestones and success criteria have been established for Phase-1. In Phase-2, four aims are proposed so as to perform non-GLP (good laboratory practices) and GLP toxicity studies, and establish production under cGMP. In addition, animal studies will be done to compare microneedles to a conventional skin patch. At the conclusion of Phase-2 an IND application will be submitted to the FDA. Overall, these studies will provide the foundation to support the development of a novel and safer peanut allergy immunotherapy treatment.